FDA device listing
Dilution Plate, Phadia 250,EliA CCP Positive Control 250,EliA CCP Positive Control 2500/5000,EliA CCP Well,EliA Dummy…
FDA device listing 1277463586 · PHADIA AB
Key facts
| Proprietary names | Dilution Plate, Phadia 250,EliA CCP Positive Control 250,EliA CCP Positive Control 2500/5000,EliA CCP Well,EliA Dummy Well,EliA IgG Calibrator Strips,EliA IgG Calibrator Well,EliA IgG Conjugate 200,EliA IgG Conjugate 50,EliA IgG Curve Control Strips,EliA Sample Diluent,Phadia 2500E, Phadia 2500EE, Phadia 5000E, and Phadia 5000E+E |
|---|---|
| Owner/operator | PHADIA AB |
| Owner/operator number | 9004441 |
| Premarket submissions | K061165 |
| Product codes | NHX |
| Device names | NHX - Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp) |
| Device class | Class II |
| Classification regulations (21 CFR) | 866.5775 |
| Review panels | Immunology |
| Registered establishments | PHADIA AB, PHADIA GMBH, PHADIA US INC. |
| Establishment registrations | 9610566, 9680745, 3004973408, 3039353646 |
| FEI numbers | 3002807876, 3004973408, 3005774014, 3039353646 |
| Establishment operations | Complaint File Establishment, Manufacturer, Contract Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database